PROCEDURE AND RECORD MAINTAIN OF LOAN AND LICENCE BASIS JOB WORK

[nandankumar roy]

DEAR SIR,

WE ARE NOW GOING TO LOAN AND LICENCE BASIS JOB WORK FOR MANUFACTURING OF PHARMA PRODUCTS.PLEASE HELP WHAT WE HAVE  TO FOLLOW PROCEDURES AND RECORD MAINTAINANCE FOR THAT JOB WORK.

NANDANROY

[Mahir S]

1) Under Drugs and Cosmetics Act, the scheme of loan licensee is permissible and the concept of manufacturer as stipulated under the Central Excise Act also covers such licensees being treated as manufacturers.

2) Application for loan licence to be made under Rule 138-A of the Drugs and Cosmetics Rules, 1945.

3) Prior Intimation to be given to the excise department.

4) regarding excise, raw material received from loan licensee to be strored separately and clearances to be effected on payment of excise duty and to be shown separately in ER 1 returns.

5) Separate register for receipt and disposal of raw materials and goods manufactured to be maintained.

6) The production should be strictly in accordance with the input outout norms.

7) Prior agreement with the loan licesee is must.

AI Summary

Loan licence manufacturing: follow statutory application, excise intimation, separate storage and duty-paid clearances, and maintain production norms and registers. Loan licence manufacture is permissible and licensees are treated as manufacturers. Apply for the loan licence under the Drugs and Cosmetics rules and give prior intimation to excise; a prior agreement with the loan licensee is required. Raw materials from the loan licensee must be stored separately, clearances effected on payment of excise duty and shown separately in ER 1 returns. Maintain a separate register for receipt and disposal and ensure production conforms to input output norms.